FDA Intel

Gland Pharma Limited

Form 483 issued May 16, 2019 · Hyderabad, India

Inspection
May 6 – May 16, 2019
Investigator
Michael A. Charles
Observations
7
Pages
6
FEI number
3002647489

In short: On May 16, 2019, FDA issued a Form 483 with 7 observations to Gland Pharma Limited in Hyderabad, Telangana (FEI 3002647489) after an inspection that ran May 6 – May 16, 2019. The investigator was Michael A. Charles. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

5 of 7 observations on this 483 concern facilities & equipment.

Facilities & equipment5
Quality system1
Laboratory controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.192

    Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. a)…

  2. 02
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. a) Although a surface…

  3. 03
    21 CFR 211.67(b)(2)

    Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including…

  4. 04
    21 CFR 211.56(c)

    Observation 4: scanned text, readable in the full document.

3 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Michael A. Charles

29 documents · 2013–2024

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.

The firm

Gland Pharma Limited history

All 6 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Gland Pharma Limited?

FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

Who inspected Gland Pharma Limited?

Michael A. Charles is named on this Form 483, for the inspection of May 6 – May 16, 2019. Each investigator has a profile showing what they cite most.

When was Gland Pharma Limited inspected by FDA?

The inspection ran May 6 – May 16, 2019, and the Form 483 is dated May 16, 2019.

How do I get the full Form 483 for Gland Pharma Limited?

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