FDA warns Indian firm over cleanliness and poor record keeping, US drugmaker over investigation failures
The US Food and Drug Administration (FDA) recently issued two warning letters to companies in India and the US for various violations of good manufacturing practices (GMPs) related to the production of drug products. In both cases, investigators identified issues with cleanliness levels within the facilities.In another recent action, the FDA sent a warning letter to a sperm donation center in San Diego for not screening samples for infectious diseases and for failing to obtain a complete medical history from donors.
Granules
On February 26, the FDA issued a warning letter to Granules India Limited in Telangana, India, outlining numerous GMP violations, including inadequate facility cleanliness and poor document control.
Investigators found bird droppings and feathers on air purification units, ducts, a tank, and floors inside the facility. The warning letter states that “the conditions in your AHU [air handling unit] raise concerns about potential contamination affecting the air supplied to critical manufacturing equipment utilized in your drug manufacturing process.”
Investigators also found “significant contamination” in multiple ducts of non-dedicated equipment used to prepare finished drug products.
For example, swab samples collected from the ducts during the inspection indicated residues from multiple previously manufactured drug products and residues of too numerous to count (TNTC) microbial contamination.
The letter stated that “air flow over dirty surfaces can facilitate contamination of the drug being processed in [redacted]. Robust design, cleaning, and maintenance of this and other equipment are critical to prevent cross-contamination.”
FDA also took issue with the firm’s handling of GMP records. Investigators said that “a large amount of torn CGMP records were discovered in at least 15 plastic waste bags during the inspection, including analytical balance printouts and worksheets containing manufacturing and testing data.”
The firm has 15 days to respond to the warning letter.
Chem-Tech
FDA also warned Chem-Tech, located in Pleasantville, Iowa, for multiple GMP violations for its over-the-counter (OTC) products uncovered during a four-day inspection in September 2024. For one, investigators said the company failed to adequately investigate out of specification (OOS) batch failures.
The company claimed that a deviation report for an OOS related to assay content was due to improper mixing, but this conclusion was reached without a thorough investigation.
The company did not conduct validation studies for the mixing process or studies on the hold time of finished products. Its validation report only includes the filling operation and omits mixing parameters. Furthermore, the holding time was altered without adequate supporting data.
Investigators have found evidence that a batch was held for up to 120 days before being filled without undergoing additional testing. FDA states that “the extended hold time of the finished drug product and inadequate validation of the process may contribute to both the high- and low-OOS assay results reported, and your cursory investigation lacked appropriate CAPA.”
The company also kept the facility in a poor state of repair, with its mixing tank and filling lines located in a “large, unclean area.” In this area, an investigator “observed a layer of dirt and a dead insect on the lid of your mixing tank that was only partially covered by a plastic sheet.”
The investigators found residual drug product at the bottom of the mixing tank. They also noted an orange-red discoloration on the inside walls and floor of the tank.
FDA stressed the importance of maintaining facilities in good repair and ensuring sanitary conditions to ensure continued suitability for drug manufacturing and to protect the product from contamination.
The firm issued a product recall due to the GMP violations cited in the warning letter and has ceased producing drugs.
Fertility Center of California
A California sperm bank called the Fertility Center of California, located in San Diego, received a warning from FDA for failing to test donors for infectious diseases and for failing to perform complete donor screenings.
This included a failure to screen for West Nile Virus (WNV) using an FDA-licensed nucleic acid test (NAT). The firm also failed to perform complete donor screening, which included a review of the relevant medical records, a medical history interview, and a physical assessment of the donor.
If the company has embryos in storage for which the donor eligibility requirements under 21 CFR 1271 were not met, the FDA considers the donor eligibility requirements to be incomplete and states that the embryos must remain in quarantine.
Warning Letters: Granules, Chem-Tech, Fertility Center of California
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