Catalent Maryland, Inc.
Form 483 issued June 19, 2020 · Harmans, Maryland
- Inspection
- Jun 15 – Jun 19, 2020
- Observations
- 5
- Pages
- 3
- FEI number
- 3015434301
In short: On June 19, 2020, FDA issued a Form 483 with 5 observations to Catalent Maryland, Inc. in Harmans, Maryland (FEI 3015434301) after an inspection that ran Jun 15 – Jun 19, 2020. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 4 of 5 observations.
Most cited: 21 CFR 211.192 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Standard operating procedures (SOPs)…
- 02
Inadequate review and trending…
- 03
Inadequate controls for the prevention…
- 04
Measures to prevent the recurrence of cracks and leaking in cell culture vessels used for (b)…
This inspection in context
Questions about this 483
What did FDA find at Catalent Maryland, Inc.?
FDA listed 5 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Catalent Maryland, Inc. inspected by FDA?
The inspection ran Jun 15 – Jun 19, 2020, and the Form 483 is dated June 19, 2020.
How do I get the full Form 483 for Catalent Maryland, Inc.?
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.