FDA Chides Dr. Reddy’s for Failing to Fully Investigate API Complaints
Regulatory News | 30 July 2019 |
The US Food and Drug Administration (FDA) sent a Form 483 to active pharmaceutical ingredient (API) manufacturer Dr. Reddy’s Bollaram, India-based site, raising concerns about the company’s failure to respond to customer complaints about out-of-specification (OOS) results.
FDA says Dr. Reddy’s received three complaints related to microbiological failures that did not meet the customer specifications for certain API lots, and Dr. Reddy’s testing confirmed the OOS microbiological failures.
“However, you did not determine a root cause of the increase in TAMC [total aerobic microbial count] and bioburden counts and just accepted the returned material,” the Form 483 says.
The site also failed to evaluate whether the finished APIs and retention samples stored in areas where relative humidity is not controlled or monitored “are affected by extreme fluctuations in humidity,” FDA says. “You have not adequately assessed whether the uncontrolled humidity conditions can affect the quality, purity and potency of your finished APIs and API retention samples during long-term storage.”
FDA also says it received several complaints in which customers were shipped the wrong type of finished API, confirming that the Dr. Reddy’s site’s bar code system is not adequate.
In addition, the agency saw during the five-day inspection earlier this month raw materials that were being stored in extreme heat and humidity, and not in accordance with the manufacturers’ storage requirements.
FDA also says it allowed the site’s personnel to collect photographs “using explosion proof cameras” that FDA inspectors requested, although the photos “came back incomplete, blurry, partially captured, or not at all. It took three attempts to collect all of the requested photos and during the second attempt we directly observed one of your employees capturing photos using his cellular telephone despite your instruction to us that we were not allowed to have cellular phones in that area,” the 483 says.
Similarly, Indian API manufacturer Cipla received a Form 483 following a five-day inspection in July. FDA notes how the site’s staff said photographs should be taken with an explosion-proof camera but “all of the photographs collected by your staff were acquired using a normal camera with a flash option.”
Dr. Reddy’s Form 483
Cipla Form 483
FDA says Dr. Reddy’s received three complaints related to microbiological failures that did not meet the customer specifications for certain API lots, and Dr. Reddy’s testing confirmed the OOS microbiological failures.
“However, you did not determine a root cause of the increase in TAMC [total aerobic microbial count] and bioburden counts and just accepted the returned material,” the Form 483 says.
The site also failed to evaluate whether the finished APIs and retention samples stored in areas where relative humidity is not controlled or monitored “are affected by extreme fluctuations in humidity,” FDA says. “You have not adequately assessed whether the uncontrolled humidity conditions can affect the quality, purity and potency of your finished APIs and API retention samples during long-term storage.”
FDA also says it received several complaints in which customers were shipped the wrong type of finished API, confirming that the Dr. Reddy’s site’s bar code system is not adequate.
In addition, the agency saw during the five-day inspection earlier this month raw materials that were being stored in extreme heat and humidity, and not in accordance with the manufacturers’ storage requirements.
FDA also says it allowed the site’s personnel to collect photographs “using explosion proof cameras” that FDA inspectors requested, although the photos “came back incomplete, blurry, partially captured, or not at all. It took three attempts to collect all of the requested photos and during the second attempt we directly observed one of your employees capturing photos using his cellular telephone despite your instruction to us that we were not allowed to have cellular phones in that area,” the 483 says.
Similarly, Indian API manufacturer Cipla received a Form 483 following a five-day inspection in July. FDA notes how the site’s staff said photographs should be taken with an explosion-proof camera but “all of the photographs collected by your staff were acquired using a normal camera with a flash option.”
Dr. Reddy’s Form 483
Cipla Form 483
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