Wockhardt Limited
Form 483 issued December 15, 2015 · Ankleshwar, India
- Investigator
- Daniel J. Roberts
- Observations
- 2
- Pages
- 7
In short: On December 15, 2015, FDA issued a Form 483 with 2 observations to Wockhardt Limited in Ankleshwar, India. The investigator was Daniel J. Roberts. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.180 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Record entries documenting your operations shall be made contemporancously and permanently in spaces provided for such…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to…
This inspection in context
Daniel J. Roberts
14 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmWockhardt Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wockhardt Limited?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Wockhardt Limited?
Daniel J. Roberts is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Wockhardt Limited inspected by FDA?
This Form 483 is dated December 15, 2015.
How do I get the full Form 483 for Wockhardt Limited?
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.