Inspections, Compliance, Enforcement, and Criminal Investigations
Pimpy's Water Delivery 19-Oct-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
466 Fernandez Juncos Avenue
Puerta De Tierra
San Juan, Puerto Rico 00901-3223
October 19, 2001
Return Receipt Requested
Mr. Rudolph Thomas
Pimpy?s Water Delivery
1 Z Estate Constant
St. John, U.S.V.I. 00801
Dear Mr. Thomas:
On May 18, 2001, the Food & Drug Administration conducted an inspection of you water bottling plant located at 1Z Estate Constant, St. John, U.S.V.I. Evaluation of the findings from this inspection reveal that the bottled drinking water produced at your plant is adulterated within the meaning of Section 402 (a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) because it was not manufactured in accordance with the requirements of Title 21, Code of Federal Regulations, Part 129 (21 CFR 129): Processing and Bottling of Bottled Drinking Water and 21 CFR 110, Current Manufacturing Practice in Manufacturing.- Packing, or Holding Human Food. The deviations found during the inspection include the following:
1. Failure to test source water from a private well for microbiological contamination at least once each week as required by 21 CFR 129.35 (a)(3).
Source water is sampled and analyzed for microbiological contamination only once every six months.
2. The water bottling room is not separated from other plant operations either by being located in a sealed area or by use of other adequate protection to preclude contamination of the water and the system, as required by 21 CFR 129.20 (a) & (b).
The room where bottling is performed is not enclosed. The doors and windows were not screened to protect against the entry of pests and remained open during processing. Washing of returned multi-use containers was performed in the same room where the bottling operations were performed.
3. Storage tanks used to hold processed water were not suitable for use for this purpose as required by 21 CFR 129.40 (b).
The storage tanks used to hold processed water are stored outside the plant and had unprotected openings that would allow the entry of pests and contamination into the storage tanks.
4. There were no records to assure that product water contact surfaces, pipes and equipment used for the processing, handling and storage of product water were adequately cleaned and sanitized as required by 21 CFR 129.37 (1) and 129.80 (d).
An unspecified amount of household bleach is added to multi-use containers, caps, hoses and other processing equipment and mixed with water. There was no standardized procedure specifying the amounts of sanitizing chemical to be used or the length of exposure time. No records were maintained of the sanitizing operation.
5. Unit containers of product water are not identified with a production code or lot number. In addition, no production records are maintained recording the kind of product, volume, and date produced as required by 21 CFR 129.80 (e).
You should take prompt action to correct these deviations and prevent their recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Regulatory actions include seizure and/or injunction.
Please notify this office in writing within 15 working days of your-receipt of this letter as to the specific actions that you have taken to correct the noted violations.
Your response should include an explanation of the steps taken to prevent similar violations in the future. If corrective actions can not be completed within 15 working days, state the reason for the delay and the time within which corrective actions will be completed. Your reply should be sent to the U.S. Food & Drug Administration to the attention of Mary L. Mason, Compliance Officer, at the address listed on the letterhead.
Wayne Matthews for Mildred R. Barber