FDA WARNING_LETTER - Intega Skin Sciences Inc. - May 27, 2016

The FDA inspected Intega Skin Sciences, Inc.'s drug manufacturing facility in Laval, Quebec, from May 24-27, 2016, identifying significant violations of current good manufacturing practice (CGMP) regulations (21 CFR Parts 210 and 211). The firm's drug product is deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. Failure to thoroughly investigate out-of-specification results, such as a microbial count exceeding specifications for lot (b)(4), and extend investigations to other affected lots (21 CFR 211.192). 2. Failure to establish written responsibilities and procedures for the quality control unit, lacking critical procedures for out-of-specification review, complaint handling, and change control (21 CFR 211.22(d)). 3. Failure to ensure equipment is cleaned at appropriate intervals and establish adequate written cleaning procedures, specifically lacking cleaning validation studies for non-dedicated equipment (21 CFR 211.67). 4. Failure to establish adequate written procedures for handling drug product complaints, including review by the quality control unit and investigation determination (21 CFR 211.198). 5. Failure to establish adequate written procedures for production and process control, specifically not validating manufacturing processes to assure