Mei Lan Thailand Co., Ltd.
FDA issued a warning letter to Mei Lan Thailand Co., Ltd. (Samut Sakhon, Thailand) on Jan 22, 2024. Subject: CGMP, Active Pharmaceutical Ingredient (API), Adulterated, Refused Inspection.
From the letter: “On May 23, 2023, the FDA sent an electronic notice of inspection to the contact email address provided in your registration file.”
At a glance
What a reviewer notes before reading: findings, citations, the response deadline and what the letter warns of.
- Violations
- 2 findings · 1 issue type
- Cited
- No CFR or ISO section
- Response due
- Not stated in the letter
- FDA asks for
- 3 actions
- Named as possible actions
- Import alert, refusal of admission
- Issued by
- Center for Drug Evaluation and Research
- Published status
- No close-out recorded
AI assisted findings
Model-assisted reading of each issue. Open one to see the FDA text it comes from, and check it against the full letter.
01Registration, listing & premarketOn May 23, 2023, FDA sent an electronic notice of inspection, but the firm failed to respond to this and subsequent requests, constituting delay.
On May 23, 2023, the FDA sent an electronic notice of inspection to the contact email address provided in your registration file. This request went unanswered, as did the second and third email requests sent on June 6 and 21, 2023, respectively.
02Registration, listing & premarketThe FDA also attempted to contact the firm via the U.S. Agent and a written request via UPS, but the firm failed to respond.
An FDA representative then attempted to contact your U.S. Agent on August 25, 2023. A fourth email attempt to contact you was sent on August 29, 2023, but you failed to respond. The Agency then sent a follow-up written request via UPS, that was delivered to the physical address provided in your registration file on August 29, 2023. Delivery to you was confirmed by the shipper, but you failed to respond.
What FDA requested
- Respond to this letter in writing within 15 working days
- Provide additional information for consideration
- Submit a request to schedule an FDA inspection
FDA Warning Letter
13 paragraphs · 1 sectionText as published on FDA.gov, retrieved Sep 8, 2026. Layout added for reading; the wording is FDA’s. View on FDA.gov (opens in a new tab)
1Letter text
11 paragraphs
Warning Letter 320-24-16
January 22, 2024 Dear Mrs. Lan Pu:
The U.S. Food and Drug Administration (FDA) notified your site, Mei Lan (Thailand) Co., Ltd., FEI 3012190301, at 35/252-253 Moo 2 , Tambol Bangnamched, Muang District, Muang Samut Sakhon, Samutsakorn, Thailand, of a planned inspection of your drug manufacturing facility from September 18 to 22, 2023.
Your firm is registered as an active pharmaceutical ingredient (API) manufacturer and manufactures crude (b)(4).
On May 23, 2023, the FDA sent an electronic notice of inspection to the contact email address provided in your registration file. This request went unanswered, as did the second and third email requests sent on June 6 and 21, 2023, respectively. An FDA representative then attempted to contact your U.S. Agent on August 25, 2023. A fourth email attempt to contact you was sent on August 29, 2023, but you failed to respond. The Agency then sent a follow-up written request via UPS, that was delivered to the physical address provided in your registration file on August 29, 2023. Delivery to you was confirmed by the shipper, but you failed to respond.
Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection.
See FDA’s guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, at https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm360484.pdf.
FDA placed your firm on Import Alert 55-03 on January 18, 2024.
Until FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Mei Lan (Thailand) Co., Ltd., at 35/252-253 Moo 2, Tambol Bangnamched, Muang District, Muang Samut Sakhon, Samutsakorn, Thailand into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices, and/or submit a request to schedule an FDA inspection.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012190301 and ATTN: Rokhsana Jazi.
Citations and trends
Each 21 CFR section, ISO 13485 clause and issue type in this letter, how often it appears across all letters, and its trend by the year FDA issued the letters. 2026 runs to Nov 3, 2026, compared with the same dates last year. Select a row or a bar to see those letters in Letters. As cited in this historical letter, not a statement of current requirements.
This letter cites no 21 CFR section or ISO 13485 clause.
Issue types
Record details
- Issuing center
- Center for Drug Evaluation and Research
- Issuing office
- Center for Drug Evaluation and Research
- Location
- Samut Sakhon, Thailand
- Letter posted date
- Jan 30, 2024
- Letter issue date
- Jan 22, 2024
- Addressed to
- Managing Director
- Inspection dates
- Sep 18, 2023
- Response window
- Not verified in this snapshot. Consult the original letter.
- Record length
- 425 words · 1 recorded redactions
- Published status
- No published close-out
- Original letter
- View on FDA.gov (opens in a new tab)
- Dataset last checked
- Nov 11, 2026 · How this is built
A response window is not a calculated due date. Source excerpts are selected passages. Finding interpretations and categories are model-assisted. Verify the original letter before relying on a finding.