Warning Letter: Ranbaxy Cited for CGMPs Deviations

On June 15, 2006, the US Food and Drug Evaluation's Center for DrugEvaluation and Research (Rockville, MD, www.fda.gov) issued a 7-page warning letter toRanbaxy Laboratories (Himachal Pradesh, India, www.ranbaxy.com) forviolations to US current good manufacturing practices (CGMPs).

Investigators found "significant deviations" to CGMP regulations duringa Feb. 20-25 inspection of the company's pharmaceutical manufacturingfacility in Paonta Sahib, India. Ranbaxy issued three responses (March20, April 20, May 25) to the observations noted in an InspectionalObservations (FDA 483) form at the end of the inspection, but FDA stillhas several concerns:

• Laboratory records did not include complete records of operatingconditions and settings used for analysis or raw stability dataacquired during drug product and lot testing (21 CFR 211.194[a][4]).

• Ranbaxy did not establish and follow a written stability testingprogram to assess drug product stability and to determine storageconditions and expiration dates. Stability sample test intervals wereundocumented (21 CFR211.166[a][1]) and storage conditions were not adequately documented (21 CFR 211.166[a][2]).

• The quality control unit does not have the personnel and theequipment to conduct proper drug stability testing (21 CFR 211.22.[b]).

FDA said in its letter, "Until FDA has confirmed correction of thedeficiencies observed during the most recent inspection and compliancewith CGMPs, this office will recommend withholding approval of any newapplications listing your Paonta Sahib facility as the manufacturer offinished pharmaceutical drug products."