FDA warns four firms in India and Germany for GMP, BIMO violations

The US Food and Drug Administration (FDA) recently sent warning letters to three companies concerning facilities in India and one in Germany for current good manufacturing practices (GMPs) and nonclinical study-related violations.

The three Indian firms included an over-the-counter (OTC) drugmaker, a manufacturer of active pharmaceutical ingredients (APIs), and a contract research organization (CRO), while the German company produces sterile drugs.

Two of the inspections were unannounced, reflecting FDA’s move in May 2025 to increase unannounced inspections at foreign manufacturing facilities that produce foods, medicines, and other medical products intended for American consumers. (RELATED: FDA to expand unannounced foreign inspections after Trump executive order, Regulatory Focus 6 May 2025)

Insanitary conditions

FDA sent a warning letter to Patcos Cosmetics on 12 March citing multiple GMP violations. The issues included insanitary conditions and a facility in a poor state of repair. The company produces private-label OTC oral care and aerosol products, including toothpaste, deodorants, and hair sprays. The inspection was conducted without prior notice.

FDA conducted a five-day inspection of the company’s facility in Daman, Dadra, and Nagar Haveli and Daman, India in July 2025. The warning letter included photographs of the facility's conditions, which is uncommon.

“Your production operations, including filling lines, are conducted in a facility that lacks adequate separation barriers from the external environment,” states the letter. “Specifically, our investigators observed evidence of harborage areas, broken windows, insanitary production-area sinks, and significant water damage in areas where open processing lines are located and where finished drug products are stored.”

Investigators found that “harborage” areas immediately outside the first floor of the facility had “discarded piping with window-grate openings to the exterior of the facility.” A broken window was also found outside the first floor, which failed to protect open processing lines from “potential contamination with filth” from the outside environment.

Other GMP violations included the firm’s failure to maintain buildings in a good state of repair. FDA said that during a 2017 FDA inspection, investigators noted that your facility was in disrepair and had experienced flood damage. “Our current inspectional findings were commensurate with findings from 2017, indicating that you have not properly remediated and maintained your facility.”

In addition, investigators said the floor of your facility “showed evidence of significant water damage with brown discoloration of the ceiling and walls and green mold-like residue on the ceiling in retained product storage areas.”

The firm remains on an import alert and has 15 days to correct the violations noted in the warning letter. FDA said that the company never addressed the problems raised in an earlier warning letter and import alert.

Aseptic processing

FDA sent sterile drug manufacturer Simtra BioPharma Solutions a warning letter citing violations related to aseptic processing at its Halle/Westphalia, Germany facility after investigators discovered numerous inadequate aseptic practices in the cleanroom during a weeklong inspection in last September.

The company is a contract development and manufacturing organization (CDMO) that produces sterile injectables. The inspection was also unannounced and took place at the former site of Baxter Oncology.

FDA said that “significant deficiencies” were identified with aseptic processing controls: in its restricted access barrier system (RABS) processing lines used to aseptically manufacture sterile drug products for the US market.

Investigators said the firm used an unnamed liquid to rinse critical interior surfaces and aseptic processing equipment in its RABS lines after production. The liquid was fed through “excessively long” deadlegs from the production loops. Deadlegs are known to cause stagnation and excessive microbial growth.

Routine testing conducted between June 2023 and September 2025 in the ISO 5 and RABS areas yielded at least 47 microbial recoveries, including 14 that exceeded the action limit. The letter states that “your routine monitoring samples repeatedly recovered gram-negative, biofilm-forming, [redacted] organisms including Sphingomonas, Methylobacterium, Bradyrhizobium, and Ralstonia species.”

Post-production environmental monitoring (EM) samples taken within the ISO 5 and RABS between June 2023 and September 2025 also resulted in repeated recoveries of gram-negative organisms including Sphingomonas, Methylobacterium, and Cupriavidus species.

FDA gave the company 15 days to correct the violations noted in the warning letter.

Raw materials

Flowchem Pharma Private in Andhra Pradesh, India received a warning letter dated 11 March citing numerous violations tied to its manufacturing of APIs. The company's products bulk active ingredient with listings of products like atropine sulfate, clobazam, and cyclobenzaprine.

The firm was reprimanded for failing to clean equipment and utensils to prevent contamination of its intermediates and APIs.

The letter states that “FDA documented an unidentified [redacted] residue, apparent rust, and unidentified liquids inside or on product contact surfaces of various non-dedicated process equipment used in the production of [redacted]. Each was marked as cleaned and ready for use. Additionally, investigators observed discolored and scratched [redacted] containers for use in [redacted] operations.”

FDA said the firm also failed to ensure that materials were handled and stored in a manner to prevent degradation and contamination. “You stored bags of raw materials outside your facility without adequate protection. Our investigators observed multiple bags of material, containing API, that were open and exposed to the environment. These bags were observed adjacent to an area undergoing apparent construction, an activity which may generate airborne dust and debris.”

On 22 January 2026, FDA placed drugs from this facility on an import alert.

BIMO violations

Vedic Lifesciences, a contract research organization (CRO) based in Mumbai, India, received a warning letter dated 6 March regarding “objectionable conditions” related to its management and oversight of nonclinical studies. This letter was issued following an inspection conducted over two days in January 2025.

FDA found falsified and inaccurate final study reports that raised data integrity concerns and the validity of the studies. The inspection was conducted as part of FDA’s Bioresearch Monitoring Program (BIMO).

FDA said the final reports for studies “did not accurately identify the testing facility that performed the studies.” Further before submitting the final reports, “Vedic changed the final reports to falsely include the name and address of Vedic as the testing facility that performed the study.”

Before submitting the final reports to the sponsor, Vedic “changed the final reports provided by the testing facilities that performed the study to falsely include the names of Vedic personnel as the study director or QAU personnel.”

In addition, the final reports did not accurately specify the storage location for all specimens, raw data, and final reports. In particular, before submitting these reports to the sponsor, Vedic altered the documents to incorrectly indicate that Vedic was the storage location, while in reality, all specimens, raw data, and final reports were stored at a different location.

The study directors did not sign the final reports for these studies. The personnel from Vedic who signed the reports were not involved in conducting the studies, as these were carried out at other testing facilities. Consequently, the Vedic staff who signed the final reports were not responsible for overseeing the studies.

Patcos, Simtra, Flowchem, Vedic

FDA warns four firms in India and Germany for GMP, BIMO violations

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