C.P.M. ContractPharma GmbH
Form 483 issued July 5, 2019 · Feldkirchen-Westerham, Germany
- Inspection
- Jul 1 – Jul 5, 2019
- Investigator
- Anita Narula
- Observations
- 4
- Pages
- 4
- FEI number
- 3005466331
In short: On July 5, 2019, FDA issued a Form 483 with 4 observations to C.P.M. ContractPharma GmbH in Feldkirchen-Westerham, Germany (FEI 3005466331) after an inspection that ran Jul 1 – Jul 5, 2019. The investigator was Anita Narula. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Laboratory records are deficient in that they do not include a complete record of all…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Anita Narula
13 documents · 2014–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Oregon.
The firmC.P.M. ContractPharma GmbH history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at C.P.M. ContractPharma GmbH?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected C.P.M. ContractPharma GmbH?
Anita Narula is named on this Form 483, for the inspection of Jul 1 – Jul 5, 2019. Each investigator has a profile showing what they cite most.
When was C.P.M. ContractPharma GmbH inspected by FDA?
The inspection ran Jul 1 – Jul 5, 2019, and the Form 483 is dated July 5, 2019.
How do I get the full Form 483 for C.P.M. ContractPharma 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.