Gland Chemicals Private Limited
Form 483 issued August 7, 2018 · Waluj, India
- Investigator
- Anastasia M. Shields
- Observations
- 6
- Pages
- 4
- FEI number
- 3003983454
In short: On August 7, 2018, FDA issued a Form 483 with 6 observations to Gland Chemicals Private Limited in Waluj, Maharashtra (FEI 3003983454). The investigator was Anastasia M. Shields. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Quality Unit failed to complete a satisfactory evaluation before release of…
- 02
In-process materials are not tested for identity, strength, quality, purity and approved or rejected by the…
- 03
The Quality Unit did not ensure that there is stability data to support retest or expiry…
- 04
The master production and control records are deficient in that they do not include complete…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmGland Chemicals Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gland Chemicals Private Limited?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Gland Chemicals Private Limited?
Anastasia M. Shields is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Gland Chemicals Private Limited inspected by FDA?
This Form 483 is dated August 7, 2018.
How do I get the full Form 483 for Gland Chemicals 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.