Pharbil Waltrop GmbH
Form 483 issued February 14, 2020 · Waltrop, Germany
- Inspection
- Feb 10 – Feb 14, 2020
- Investigator
- Russell J. Glapion
- Observations
- 2
- Pages
- 2
- FEI number
- 3004620586
In short: On February 14, 2020, FDA issued a Form 483 with 2 observations to Pharbil Waltrop GmbH in Waltrop, Germany (FEI 3004620586) after an inspection that ran Feb 10 – Feb 14, 2020. The investigator was Russell J. Glapion. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.110(a) (1×) · 211.103 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 02
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
This inspection in context
Russell J. Glapion
18 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmPharbil Waltrop GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharbil Waltrop GmbH?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Pharbil Waltrop GmbH?
Russell J. Glapion is named on this Form 483, for the inspection of Feb 10 – Feb 14, 2020. Each investigator has a profile showing what they cite most.
When was Pharbil Waltrop GmbH inspected by FDA?
The inspection ran Feb 10 – Feb 14, 2020, and the Form 483 is dated February 14, 2020.
How do I get the full Form 483 for Pharbil Waltrop 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.