Valary Lab Private Limited
Form 483 issued August 26, 2022 · Anakapalli, India
- Inspection
- Aug 22 – Aug 26, 2022
- Investigator
- Alan P. Kurtzberg
- Observations
- 2
- Pages
- 1
- FEI number
- 3019200343
In short: On August 26, 2022, FDA issued a Form 483 with 2 observations to Valary Lab Private Limited in Anakapalli, Andhra Pradesh (FEI 3019200343) after an inspection that ran Aug 22 – Aug 26, 2022. The investigator was Alan P. Kurtzberg. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.188 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Manufacturing batch records do not note deviations. Appropriate…
- 02
Manufacturing batch and control records do not contain complete information related to the manufacture and…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmValary Lab Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Valary Lab Private Limited?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Valary Lab Private Limited?
Alan P. Kurtzberg is named on this Form 483, for the inspection of Aug 22 – Aug 26, 2022. Each investigator has a profile showing what they cite most.
When was Valary Lab Private Limited inspected by FDA?
The inspection ran Aug 22 – Aug 26, 2022, and the Form 483 is dated August 26, 2022.
How do I get the full Form 483 for Valary Lab Private 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.