Pfizer Manufacturing Deutschland GmbH
Form 483 issued March 8, 2019 · Freiburg im Breisgau, Germany
- Observations
- 3
- Pages
- 3
- FEI number
- 3002807097
In short: On March 8, 2019, FDA issued a Form 483 with 3 observations to Pfizer Manufacturing Deutschland GmbH in Freiburg im Breisgau, BW (FEI 3002807097). Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigation of a drug complaint do not include the findings of the investigation…
- 02
Written records of investigations into unexplained discrepancies do not always include the…
- 03
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
This inspection in context
Questions about this 483
What did FDA find at Pfizer Manufacturing Deutschland GmbH?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Pfizer Manufacturing Deutschland GmbH inspected by FDA?
This Form 483 is dated March 8, 2019.
How do I get the full Form 483 for Pfizer Manufacturing Deutschland GmbH?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.