FDA issues warning letters for GMP, GCP violations

The US Food and Drug Administration recently published several warning letters healthcare product manufacturers and a clinical investigator for failing to comply with its regulatory requirements.

In some instances, companies were cited for violations similar to previous observations from past inspections and were encouraged to retain qualified consultants to help them address their failures.

Chemspec Chemicals

Chemspec Chemicals, a drug manufacturer based in Maharashtra, India, was cited for failing to comply with current good manufacturing practices (CGMP). Investigators said that the company failed to ensure proper record-keeping.

"Your quality unit was not exercising its basic responsibilities for oversight and control of the adequacy and reliability of all CGMP data at your facility," said FDA. "In addition, your quality unit failed to ensure that employees involved in CGMP operations for APIs understand and adhere to data integrity principles."

Investigators listed several instances where the company failed to properly document its manufacturing process, including failure to ensure batch production records were completed with all the manufacturing and control information for each active pharmaceutical ingredient (API) lot, and failing to ensure data integrity.

"Your quality unit kept two separate logbooks for the issuance of lot numbers which showed that two batch manufacturing records were issued for the same lot numbers," FDA added. "In addition, we observed two API batch records in use, in production, with neither an assigned control number nor any documentation that they had been issued by the quality unit."

While the company acknowledged its failures, stated that it had recovered half of the original API batch manufacturing records, and announced that it would update its procedures, investigators deemed the response inadequate. They stated that the company did not sufficiently address and reconcile all missing batch records, and failed to provide a comprehensive retrospective evaluation, as well as any testing data and release documentation.

"You do not provide a plan or procedures to holistically improve your document lifecycle controls, issuance traceability, and quality unit release processes," said FDA. "You do not provide results from comprehensively investigating past incidents of non-contemporaneous documentation, nor have you reconciled existing batch manufacturing records for completeness and release by the quality unit."

FDA "strongly" recommended Chemspec retain a qualified consultant to address its CGMP problems and noted that the manufacturer has had similar deficiencies in past inspections where it said it would implement remediations but failed to do so.

"Repeated failures demonstrate that executive management oversight and control over the manufacture of APIs are inadequate," said the agency.

ASP Global

ASP Global, a device-maker based in the Austell, GA, was cited for failing to implement supplier management procedures and establish other adequate procedures to ensure its products conformed to specifications.

"Your supplier management procedures were not adequately implemented to ensure that product purchased from critical supplier and manufacturer of Safe-T-Fill Capillary Collection Tubes, [redacted], provided product that conform to specified requirements," said FDA. "Your firm did not verify the product’s ability to meet specified needs or [redacted] ability to produce products that do not interfere with [redacted] lead analyzers, a common lead testing technique.

"There were 26 complaints reported to ASP Global from October 2024 to April 2025 (Complaints 2024-01 through 2025-18) related to false positive lead results when Safe-T-Fill EDTA tubes were used with Magellan LeadCare systems," the agency added.

Investigators said ASP Global's lack of appropriate design controls throughout its product development lifecycle may put patients at risk and lead to inappropriate medical interventions.

While ASP Global stated that it was implementing corrective actions, investigators said that the response was inadequate because the company did not provide sufficient detail in its response. Furthermore, while the company stated that it had disqualified its previous supplier, investigators noted that it was unclear how the disqualified supplier would continue to provide services such as design control remediation activities as part of its corrective action plan.

Furthermore, ASP Global was cited for violating medical device reporting (MDR) requirements, including failing to maintain and implement adequate MDR procedures. It was also cited for failing to submit written reports to FDA about any correction or removal of a device that may pose a health risk.

Additionally, ASP Global was cited for making changes to its products without obtaining FDA clearance or approval and for labeling violations, including failing to provide an adequate description of the product.

Winder Laboratories

Winder Laboratories, a drug manufacturer based in the US state of Georgia, received a warning letter for CGMP violations, including the failure to ensure that manufacturing equipment was cleaned and sanitized for the production of drugs to ensure their safety, identity, strength, and purity.

"You have not demonstrated that your cleaning practices are adequate to remove contaminants from the nondedicated equipment used to manufacture your prescription drug products, including [redacted] tablets and [redacted] tablets," said FDA. "Multiple pieces of manufacturing equipment, including the [redacted] and the Tablet Press, were observed to have drug product residue and oxidized metal surfaces, which were documented as being clean and were released by your quality unit.

"Additionally, the dedicated [redacted] equipment showed visible product residue, oxidized metal, and foreign material, despite being cleaned and released by your quality unit," the agency added. "Similar equipment cleaning deficiencies were cited during your previous FDA inspections, indicating that your cleaning procedures are insufficient to prevent contamination that could alter the safety, identity, strength, quality, or purity of your drug products."

Winder was also cited for failing to maintain its manufacturing equipment. For example, inspectors noted that the metal detection equipment was not functioning during their inspection.

Similarly, Winder was cited for failing to maintain the buildings used for manufacturing its drugs. Inspectors noted that there were gaps in protective walls, making it hard to maintain cleanliness. Additionally, FDA noted that unknown brown-yellow material was visible in certain wall gaps, as well as an improperly secured ceiling vent and unfinished walls.

"In your response, you state that you immediately halted all manufacturing operations and promptly took corrective actions to address the specific deficiencies," said FDA. "You also indicated that you would not resume manufacturing operations until all repairs were completed, and the rooms met the required standards for cleanliness and maintenance.

Winder was told that inspectors had found similar CGMP violations during past inspections and was recommended to retain a qualified consultant to address its problems.

GCP warning

FDA cited Purushothaman Damodara Kumaran, a clinical researcher at Senthil Specialty Hospital in Puducherry, India, for failing to meet the FDA's good clinical practice (GCP) requirements. More specifically, investigators stated that Kumaran failed to follow the investigational plan, which required clinical researchers to collect safety assessments, including hematology and pulmonary function tests, from trial participants on a set periodic basis.

Inspectors noted that the investigational drug has the potential for severe side effects that could be fatal, and the tests are intended to detect adverse events early. While Kumaran argued that they modified the visit schedule for "pragmatic reasons," such as travel commitments, and that the sponsor was aware of the deviations from the investigational plan, inspectors stated that they did not provide any evidence that the sponsor had approved the changes.

"You also did not provide evidence of the telephone consultations you stated that you employed in regular follow-ups of subjects, to identify and address adverse events," said FDA. "Furthermore, your written response is inadequate because you did not provide information about any completed or proposed corrective actions that would prevent similar violations in the future."

"We emphasize that, as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data," the agency added.

Warning letters

FDA issues warning letters for GMP, GCP violations

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