A company recently received this 483 observation:
….. Adequate ventilation is not provided.
Specifically, your firm has failed to establish appropriate temperature and humidity controls and monitoring in storage and production areas that may impact the quality of drugs which are incorporated into medical kits such as …. There are no records maintained to demonstrate that drugs received, stored, and assembled into medical kits have been stored in a manner to ensure the identity, strength, quality, and purity. The facility temperature observed during the inspection was 80°F and 79°F (observed on wall thermometer in medical kit assembly production room). Your firm reportedly receives and stores drugs for up to 12 weeks prior to kit assembly and may hold finished assembled kits for up to 2 days prior to distribution to customers.
For more observations pertaining to manufacturing controls, see Issue 1042 available today. It also has observations pertaining to lab controls, sterile manufacturing controls and medical device manufacturers.